National Cancer Institute (NCI)
National Eye Institute (NEI)
National Human Genome Research Institute (NHGRI)
National Institute on Aging (NIA)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)Eunice Kennedy Shriver National Institute of Child Health and Human
Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institute on Drug Abuse (NIDA)
National Institute of Environmental Health Sciences (NIEHS)
National Institute of General Medical Sciences (NIGMS)
National Institute of Mental Health (NIMH)
National Institute of Nursing Research (NINR)
National Center for Complementary and Integrative Health (NCCIH)
National Heart, Lung, and Blood Institute (NHLBI)
Division of Program Coordination, Planning and Strategic
Initiatives, Office of Research Infrastructure Programs (ORIP)
National Institute of Neurological Disorders and Stroke (NINDS)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)Special
Note: Not all NIH Institutes and Centers participate in
Parent Announcements. Applicants should carefully note which ICs participate
in this announcement and view their respective areas of research interest and
requirements at the Table
of IC-Specific Information, Requirements and Staff Contacts website. ICs
that do not participate in this announcement will not consider applications
for funding. Consultation with NIH staff before submitting an application is
strongly encouraged.

The National Institutes of Health (NIH) will award Ruth L.
Kirschstein National Research Service Award (NRSA) Institutional Research
Training Grants (T32) to eligible, domestic institutions to enhance
predoctoral and postdoctoral research training, including short-term research
training, and help ensure that a diverse and highly trained workforce is
available to meet the needs of the Nation’s biomedical, behavioral, and
clinical research agenda. Research training programs will incorporate
didactic, research, and career development elements to prepare individuals
for careers that will have a significant impact on the health-related
research needs of the Nation. Programs proposing only short-term research
training should not apply to this announcement, but rather to the
Kirschstein-NRSA Short-Term Institutional Research Training Grant Program
(T35) exclusively reserved for predoctoral, short-term research training (see PA-18-404).

This Funding Opportunity Announcement (FOA) does not allow
appointed trainees to lead an independent clinical trial, but does allow them
to obtain research experience in a clinical trial led by a mentor or
co-mentor.

It is critical that applicants follow the Training (T) Instructions
in the SF424
(R&R) Application Guide, except where instructed to do otherwise (in
this FOA or in a Notice from the NIH
Guide for Grants and Contracts). Conformance to all requirements (both in
the Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and
Department of Health and Human Services partners. You must use one of these submission
options to access the application forms for this opportunity.

Use the NIH ASSIST system to prepare, submit and track your application online.

The overall goal of the
NIH Ruth L. Kirschstein National Research Service Award (NRSA) program is to
help ensure that a diverse pool of highly trained scientists is available in
appropriate scientific disciplines to address the Nation's biomedical,
behavioral, and clinical research needs. In order to accomplish this goal, NRSA training programs
are designed to train individuals to conduct research and to prepare for
research careers. More information
about NRSA programs may be found at the Ruth L. Kirschstein National Research Service
Award (NRSA) website.

Purpose
and Background Information

The NRSA program has been
the primary means of supporting predoctoral and postdoctoral research training
programs since enactment of the NRSA legislation in 1974. Research training
activities can be in basic biomedical or clinical sciences, in behavioral or
social sciences, in health services research, or in any other discipline
relevant to the NIH mission.

Institutional NRSA
programs allow the Training Program Director/Principal Investigator (Training
PD/PI) to select the trainees and develop a program of coursework, research
experiences, and technical and/or professional skills development appropriate
for the selected trainees. Each program should provide high-quality research
training and offer opportunities in addition to conducting mentored research.
The grant offsets the cost of stipends, tuition and fees, and training related
expenses, including health insurance, for the appointed trainees in accordance
with the approved NIH support levels.

Program Objective

The
objective of the Ruth L. Kirschstein National Research Service Award (NRSA)
Institutional Research Training Grant (T32) program is to develop and/or
enhance research training opportunities for individuals interested in careers
in biomedical, behavioral and clinical research that are relevant to the NIH
mission. The training program should provide:

A strong
foundation in research design, methods, and analytic techniques appropriate for
the proposed research area;

The
enhancement of the trainees’ ability to conceptualize and think through
research problems with increasing independence;

Experience
conducting research using state-of-the-art methods as well as presenting and
publishing their research findings;

The
opportunity to interact with members of the scientific community at appropriate
scientific meetings and workshops; and

The enhancement of the trainees’ understanding of the
health-related sciences and the relationship of their research training to
health and disease.

The
proposed institutional research training program may complement other ongoing
research training and career development programs at the applicant institution,
but the proposed program must be clearly distinct from related programs
currently receiving Federal support.

Program Considerations

The
duration of training, the transition of trainees to individual support
mechanisms, and their transition to the next career stage are important
considerations in institutional training programs. Training PDs/PIs
should limit appointments to individuals who are committed to a research career
and who plan to remain in training for no less than two years, whether that
support comes from a training grant or some combination of NRSA and non-NRSA
support programs. Training PDs/PIs should encourage and make available
appropriate skills training so that trainees are prepared to apply for
subsequent independent support for their training or research program (e.g., an
individual fellowship award, mentored career development award, or research
project grant), as appropriate for their career stage. In addition, past
studies have shown that health professional trainees who train in programs with
postdoctoral researchers who have intensive research backgrounds are more
likely to apply for and receive subsequent research grant support.
Programs that emphasize research training for individuals with the MD or other
health-professional degrees are therefore encouraged to develop ties to basic
science departments and include trainees with research doctorates when this
approach is consistent with the goals of the proposed training program.

Biomedical
research and the resulting scientific knowledge are increasingly complex and
multidisciplinary in nature. Training PDs/PIs are encouraged to develop
institutional training programs that will expose trainees to a diversity of
scientific approaches, systems for study, research approaches, and tools and
technologies. Consideration of team-based research approaches may also be
warranted depending upon the goals of the proposed training program.

Within the framework of the
NRSA program’s longstanding commitment to excellence and the projected need for
investigators in particular areas of research, attention must be given to
recruiting and retaining trainees from racial or ethnic groups underrepresented
in the biomedical, behavioral and clinical sciences, individuals with
disabilities, and individuals from disadvantaged backgrounds. See Section IV for
background.

The
career outcomes of individuals supported by NRSA training programs include both
research-intensive careers in academia and industry and research-related
careers in various sectors, e.g., academic institutions, government agencies,
for-profit businesses, and private foundations. Training programs should make available
structured, career development advising and learning opportunities (e.g.,
workshops, discussions, Individual Development Plans). Through such
opportunities, trainees are expected to obtain a working knowledge of various potential career paths
that would make strong use
of the knowledge and skills gained during research training and the steps
required to transition successfully to the next stage of their chosen career.

Institutional research training grants must be used to
support a program of full-time research training. Within the full-time training
period, research trainees who are also training as clinicians must devote their
time to the proposed research training and must confine clinical duties to
those that are an integral part of the research training experience. The
program may not be used to support studies leading to the MD, DDS, or other
clinical, health-professional degrees except when those studies are part of a
formal combined research degree program, such as the MD/PhD. Similarly,
trainees may not accept NRSA support for clinical training that is part of
residency training leading to clinical certification in a medical or dental
specialty or subspecialty. It is permissible and encouraged, however, for
clinicians to engage in NRSA-supported, full-time postdoctoral research
training even when that experience is creditable toward certification by a
clinical specialty or subspecialty board.

Short-term training is not intended, and may not be used, to
support activities that would ordinarily be part of a research degree program,
nor for any undergraduate-level training. Short-term positions should be
requested at the time of application, as described in the NIH Grants Policy Statement. Research
training programs solely for short-term research training should not apply to
this announcement, but rather the T35 NRSA FOA, which can be found in the NIH Training Kiosk.

Note: This Funding Opportunity Announcement (FOA) does not allow appointed trainees to
lead an independent clinical trial, but does allow them to obtain research
experience in a clinical trial led by a mentor or co-mentor. NIH strongly
supports training towards a career in clinically relevant research and so
gaining experience in clinical trials under the guidance of a mentor or
co-mentor is encouraged.

Special
Note: Because of the differences in individual Institute and
Center (IC) program requirements for this FOA, prospective applicants MUST consult the Table
of IC-Specific Information, Requirements and Staff Contacts, to make sure
that their application is appropriate for the requirements of one of the
participating NIH ICs. Prior consultation with NIH staff is strongly
encouraged.

The number of awards is contingent upon NIH appropriations
and the submission of a sufficient number of meritorious applications.

Award Budget

Application budgets are not limited, but need to reflect the
actual needs of the proposed project.

Grantees are expected to be familiar with and comply with
applicable cost policies and the NRSA Guidelines (NIH
Grants Policy Statement - Institutional Research Training Grants).
Funds may be used only for those expenses that are directly related to and
necessary for the research training and must be expended in conformance with
OMB Cost Principles, the NIH
Grants Policy Statement, and the NRSA regulations, policies,
guidelines, and conditions set forth in this document.

Award Project Period

Awards for T32 institutional NRSA research training grants
may be for project periods up to five years in duration and are renewable.

Other Award Budget
Information

Stipends, Tuition, and Fees

Kirschstein-NRSA awards provide stipends as a subsistence
allowance to help defray living expenses during the research training
experience.

NIH will contribute to the combined cost of tuition and fees at the rate in
place at the time of award.

Stipend levels, as well as funding amounts for tuition and fees and the
institutional allowance are announced annually in the NIH Guide for Grants
and Contracts, and are also posted on the Ruth L. Kirschstein National
Research Service Award (NRSA) webpage.

Trainee Travel

Trainee travel to attend scientific meetings and workshops
that the institution determines to be necessary for the individual’s research
training experience is an allowable trainee expense for predoctoral and
postdoctoral trainees. The amount of funds provided for trainee travel may
vary by NIH Institute or Center; applicants are encouraged to consult the Table
of IC-Specific Information, Requirements and Staff Contacts for further
information.

Training Related Expenses

NIH will provide funds
to help defray other research training expenses, such as health
insurance, staff salaries, consultant costs, equipment, research supplies,
and faculty/staff travel directly related to the research training program. The
most recent levels of training related expenses are announced annually in the NIH Guide for Grants and Contracts, and are also posted on the Ruth L.
Kirschstein National Research Service Award (NRSA) webpage

Indirect Costs

Indirect Costs (also known as Facilities &
Administrative [F&A] Costs) are reimbursed at 8% of modified total direct
costs (exclusive of tuition and fees, consortium costs in excess of $25,000,
and expenditures for equipment), rather than on the basis of a negotiated
rate agreement.

NIH grants policies as
described in the NIH
Grants Policy Statement will apply
to the applications submitted and awards made from this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

Public/State Controlled Institutions of Higher Education

Private Institutions of Higher Education

The following types of Higher
Education Institutions are always encouraged to apply for NIH support as Public
or Private Institutions of Higher Education:

The sponsoring institution must assure support for the
proposed program. Appropriate institutional commitment to the program includes
the provision of adequate staff, facilities, and educational resources that can
contribute to the planned program.

The applicant institution
must have a strong and high quality research program in the area(s) proposed
under this FOA and must have the requisite faculty, staff, potential trainees, and facilities on site to conduct the proposed
institutional program. In many cases, it is anticipated that the
proposed program will complement other ongoing training and career development
programs occurring at the applicant institution and that a substantial number
of program faculty will have active research projects in which participating trainees
may gain relevant experiences consistent with their research interests and
goals.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are
not eligible to apply.

Required Registrations

Applicant
Organizations

Applicant organizations must complete and maintain the
following registrations as described in the SF 424 (R&R) Application Guide
to be eligible to apply for or receive an award. All registrations must be
completed prior to the application being submitted. Registration can take 6
weeks or more, so applicants should begin the registration process as soon as
possible. The NIH
Policy on Late Submission of Grant Applications states that failure to
complete registrations in advance of a due date is not a valid reason for a
late submission.

Dun and Bradstreet
Universal Numbering System (DUNS) - All registrations require that
applicants be issued a DUNS number. After obtaining a DUNS number, applicants
can begin both SAM and eRA Commons registrations. The same DUNS number must be
used for all registrations, as well as on the grant application.

System for Award Management (SAM) (formerly CCR) – Applicants must complete and maintain an active registration, which requires renewal at least
annually. The renewal process may require as much time as the
initial registration. SAM registration includes the assignment of a Commercial
and Government Entity (CAGE) Code for domestic organizations which have not
already been assigned a CAGE Code.

eRA Commons - Applicants
must have an active DUNS number and SAM registration in order to complete the
eRA Commons registration. Organizations can register with the eRA Commons as
they are working through their SAM or Grants.gov registration. eRA Commons
requires organizations to identify at least one Signing Official (SO) and at
least one Program Director/Principal Investigator (PD/PI) account in order to
submit an application.

Grants.gov – Applicants
must have an active DUNS number and SAM registration in order to complete the
Grants.gov registration.

Program
Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.
PD(s)/PI(s) should work with their organizational officials to either
create a new account or to affiliate their existing account with the applicant
organization in eRA Commons.If the PD/PI is also the organizational Signing
Official, they must have two distinct eRA Commons accounts, one for each role.
Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal
Investigator)

Any individual(s) with
the skills, knowledge, and resources necessary to carry out the proposed research training program as the
Training Program Director/Principal Investigator (Training PD/PI) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for NIH support.

The Training PD/PI should be an established investigator in
the scientific area in which the application is targeted and capable of
providing both administrative and scientific leadership to the development and
implementation of the proposed program. The PD/PI will be responsible for the
selection and appointment of trainees to the approved research training
program, and for the overall direction, management, administration, and
evaluation of the program. The PD/PI will be expected to monitor and assess the
program and submit all documents and reports as required. The PD/PI has
responsibility for the day to day administration of the program and is
responsible for appointing members of the Advisory Committee (when applicable),
using their recommendations to determine the appropriate allotment of funds.

Applicant organizations may submit more than one application,
provided that each application is programmatically distinct.

The NIH will not accept duplicate or highly overlapping
applications under review at the same time. This means that the NIH will
not accept:

A new (A0) application that is submitted before issuance of the
summary statement from the review of an overlapping new (A0) or resubmission
(A1) application.

A resubmission (A1) application that is submitted before issuance
of the summary statement from the review of the previous new (A0) application.

An application that has substantial overlap with another
application pending appeal of initial peer review (see NOT-OD-11-101).

Preceptors/Mentors

Program
faculty should have strong records as researchers, including recent
publications and successful competition for research support in the area of the
proposed research training program. Program faculty should also have a
record of research training, including successful, former trainees who have
established productive careers relevant to the NIH mission. Researchers
from diverse backgrounds, including racial and ethnic minorities, persons with
disabilities, and women are encouraged to participate as mentors.

Trainees

The individual to be
trained must be a citizen or a noncitizen national of the United States or have
been lawfully admitted for permanent residence at the time of appointment.
Additional details on citizenship, training period, and aggregate duration of
support are available in the NIH
Grants Policy Statement.

All
trainees are required to pursue their research training full time, normally
defined as 40 hours per week, or as specified by the sponsoring institution in
accordance with its own policies. Appointments are normally made in 12-month
increments, and no trainee may be appointed for less than 9 months during the
initial period of appointment, except with prior approval of the NIH awarding
unit, or when trainees are appointed to approved, short-term training
positions.

Pre-doctoral Trainees

Predoctoral
trainees must be enrolled in a program leading to a PhD or in an equivalent
research doctoral degree program. Health-professional students who wish to
interrupt their studies for a year or more to engage in full-time research
training before completing their formal training programs, are also eligible.

Post-doctoral Trainees

Postdoctoral
trainees must have received, as of the beginning date of the NRSA appointment,
a PhD, MD, DDS., or comparable doctoral degree from an accredited domestic or
foreign institution. Comparable doctoral degrees include, but are not limited
to, the following: DMD, DC, DO, DVM., OD, DPM, ScD, EngD, DrPH, DNSc,
DPT, PharmD, ND (Doctor of Naturopathy), DSW, PsyD, as well as a doctoral
degree in nursing research. Documentation by an authorized official of the
degree-granting institution certifying all degree requirements have been met
prior to the beginning date of the training appointment is acceptable. Individuals
in postgraduate clinical training, who wish to interrupt their studies for a
year or more to engage in full-time research training before completing their
formal training programs, are also eligible.

Short-Term Trainees

If requested, short-term trainees must be medical students,
dental students, students in other health-professional programs, or graduate
students in the physical or quantitative sciences. To be eligible for
short-term, predoctoral research training positions, students must be enrolled,
in good standing, and must have completed at least one quarter or semester in a
program leading to a clinical doctorate or a doctorate in a physical or
quantitative science such as physics, mathematics, or engineering before
participating in the training program. Individuals already matriculated in a
formal research degree program in the health sciences, or those holding a
research doctorate, a master’s degree, or a combined
health-professional/research doctorate normally are not eligible for short-term
training positions. Within schools of pharmacy, only individuals who are
candidates for the PharmD degree are eligible for short-term, research training
positions.

Trainees
selected for short-term training are required to pursue research training for
2-3 months on a full-time basis devoting at least 40 hours per week, or as
specified by the sponsoring institution in accordance with its own policies.
Within the full-time training period, trainees must devote their time to the
proposed research training and must confine clinical duties to those that are
an integral part of the research training experience. Successful trainees may
be appointed for additional periods of short-term training or, if appropriate
to their career level, they should be encouraged to apply for an extended
period of full-time training supported by an NRSA training grant or fellowship,
or an NIH career development award.

Short-term
training is not intended, and may not be used, to support activities that would
ordinarily be part of a research degree program, nor for any
undergraduate-level training.

Section IV. Application
and Submission Information

1. Requesting an
Application Package

Buttons to access the online ASSIST system or to download
application forms are available in Part
1 of this FOA. See your administrative office for instructions if you plan
to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Training (T) Instructions
in the SF424
(R&R) Application Guide except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

All page limitations described in the SF424 (R&R)
Application Guide and the Table of
Page Limits must be followed.

Instructions
for Application Submission

The following section supplements the instructions found in
the SF424 (R&R) Application Guide and should be used for preparing an
application to this FOA.

SF424(R&R) Cover

Follow all instructions provided in the SF424 (R&R)
Application Guide.

SF424(R&R) Project/Performance Site Locations

Follow all instructions provided in the SF424 (R&R)
Application.

SF424 (R&R) Other Project Information

Follow all instructions provided in the SF424 (R&R)
Application, with the following additional modifications:

Project
Summary/Abstract. Provide an abstract of the entire application.
Include the objectives, rationale and design of the research training program, as
well as key activities in the training plan. Indicate the plannedduration
of appointments, the projected number of trainees including their levels (i.e.,
predoctoral, postdoctoral, short-term) ), and intended trainee outcomes.

Other
Attachments.An Advisory Committee is not a required component of a training program. However, if an
Advisory Committee is intended, provide a plan for the appointment of an
Advisory Committee to monitor progress of the training program. The
composition, roles, responsibilities, and desired expertise of committee
members, frequency of committee meetings, and other relevant information should
be included. Describe how the Advisory Committee will evaluate the overall
effectiveness of the program. Proposed Advisory Committee members should be
named in the application if they have been invited to participate at the time
the application is submitted. Renewal applications with Advisory
Committees should include the names of all committee members during the past
project period. Please name your file “Advisory_Committee.pdf”.

The
filename provided for each “Other Attachment” will be the name used for the
bookmark in the electronic application in eRA Commons.

SF424(R&R) Senior/Key Person Profile Expanded

Follow all instructions provided in the SF424 (R&R)
Application.

PHS 398 Cover Page Supplement

Follow all instructions provided in the SF424 (R&R)
Application.

PHS 398 Training Subaward Budget Attachment(s)

Follow all instructions provided in the SF424 (R&R)
Application Guide.

Training Budget

Follow all instructions provided in the SF424 (R&R)
Application Guide with the following additional modifications:

Include all personnel other than the Training PD(s)/PI(s) in the
Other Personnel section, including clerical and administrative staff

PHS 398 Research Training Program Plan

The PHS 398 Research Training Program Plan Form is comprised
of the following sections:

Training Program

Faculty, Trainees, and Training Record

Other Training Program Sections

Appendix (Note that the Appendix should only be used in
circumstances covered in the NIH policy on appendix materials or if the FOA
specifically instructs applicants to do so).

Follow all instructions provided in the SF424 (R&R)
Application Guide with the following additional modifications:

Particular attention must be given to the required Training
Data Tables. Applicants should summarize, in the body of the
application, key data from the tables that highlight the characteristics of the
applicant pool, faculty mentors, the educational and career outcomes of
participants, and other factors that contribute to the overall environment of
the program.

Training Program

Program
Plan

Proposed Training.

The Training PD/PI should describe program activities
intended to develop the working knowledge needed for trainees to select among
and prepare for the next step in the varied research career options available
in the biomedical workforce. For example, programs should provide all trainees
with instruction and training in oral and written presentation and in skills needed
to apply for individual fellowship or grant support. All postdoctoral trainees
should also be provided with instruction in laboratory and project management.

For programs that propose short-term training, any
didactic training must be well structured and appropriately justified for the
duration of the training experience. Short-term trainees must have the
opportunity to carry out supervised biomedical, behavioral, or clinical
research with the primary objective of developing or enhancing their research
skills and knowledge in preparation for a health-related research career.

For renewal
applications, highlight how the training program has evolved in response to
changes in relevant scientific and technical knowledge, educational practices,
and to evaluation of the training program.

Plan for Instruction in the Responsible Conduct of
Research

Individuals are required to comply with the
instructions for Plan for Instruction in the Responsible Conduct of Research as
provided in the SF424 (R&R) Application Guide.

Limited items are allowed in the Appendix.
Follow all instructions for the Appendix as described in the SF424 (R&R)
Application Guide.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide
must be followed.

3. Unique Entity Identifier
and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the
requirement for obtaining a unique entity identifier and for completing and
maintaining active registrations in System for Award Management (SAM), NATO
Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and
Grants.gov

4. Submission Dates and
Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to
submit applications before the due date to ensure they have time to make any
application corrections that might be necessary for successful submission. When
a submission date falls on a weekend or Federal
holiday, the application deadline is automatically extended to the next
business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants
across all Federal agencies). Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants
administration. NIH and Grants.gov systems check the application against many
of the application instructions upon submission. Errors must be corrected and a
changed/corrected application must be submitted to Grants.gov on or before the
application due date and time. If a Changed/Corrected application is submitted
after the deadline, the application will be considered late. Applications that
miss the due date and time are subjected to the NIH Policy on Late Application
Submission.

Applicants
are responsible for viewing their application before the due date in the eRA
Commons to ensure accurate and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

All NIH awards are subject to the terms and conditions, cost
principles, and other considerations described in the NIH
Grants Policy Statement. The National
Research Service Award (NRSA) policies apply to this program. An NRSA
appointment may not be held concurrently with another Federally sponsored
fellowship, traineeship, or similar Federal award that provides a stipend or
otherwise duplicates provisions of the NRSA.

Pre-award costs are allowable only as described in the NIH
Grants Policy Statement. Note, however, that pre-award costs are not
allowable charges for stipends or tuition/fees on institutional training grants
because these costs may not be charged to the grant until a trainee has
actually been appointed and the appropriate paperwork submitted to the NIH
awarding component. Any
additional costs associated with the decision to allow research elective credit
for short-term research training are not allowable charges on an institutional
training grant.

7. Other Submission
Requirements and Information

Applications must be submitted electronically following the
instructions described in the SF424 (R&R) Application Guide. Paper
applications will not be accepted.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying
Electronically. If you encounter a system issue beyond your control that
threatens your ability to complete the submission process on-time, you must
follow the Guidelines
for Applicants Experiencing System Issues. For assistance with application
submission, contact the Application Submission Contacts in Section VII.

Important
reminders:

All PD(s)/PI(s) must include their eRA Commons ID in
the Credential fieldof the Senior/Key Person Profile Component of the
SF424(R&R) Application Package.Failure to register in the Commons
and to include a valid PD/PI Commons ID in the credential field will prevent
the successful submission of an electronic application to NIH.

The applicant organization must ensure that the DUNS number it provides on the
application is the same number used in the organization’s profile in the eRA
Commons and for the System for Award Management (SAM). Additional information
may be found in the SF424 (R&R) Application Guide.

Upon receipt, applications will be evaluated for
completeness and compliance with application instructions by the Center for
Scientific Review, NIH. Applications that are incomplete or non-compliant will
not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in
any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks
before submitting the application and follow the Policy on the Acceptance for
Review of Unsolicited Applications that Request $500,000 or More in Direct
Costs as described in the SF424 (R&R) Application Guide. Applicants are
advised to refer to Agency Contacts for
exceptions.

Post Submission Materials

Applicants are
required to follow the instructions for post-submission materials, as described
in the
policy. Any instructions provided here are in addition to the instructions
in the policy.

Section V. Application Review Information

1.
Criteria

Only the review criteria described below will be considered
in the review process. As part of the NIH mission,
all applications submitted to the NIH in support of biomedical and behavioral
research are evaluated for scientific and technical merit through the NIH peer
review system.

Overall Impact

Reviewers
will provide an overall impact score to reflect their assessment of the
likelihood that the proposed training
program will prepare individuals for successful, productive scientific research
careers and thereby exert a sustained influence on the research field(s)
involved, in consideration
of the following review criteria and additional review criteria (as applicable
for the project proposed).

Scored Review Criteria

Reviewers will consider each
of the review criteria below in the determination of the merit of the training
program, and give a separate score for each. When applicable, the reviewers will consider relevant questions in the
context of proposed short-term training. An
application does not need to be strong in all categories to be judged likely to
have major scientific impact.

Training Program
and Environment

Are
the research facilities and research environment conducive to preparing
trainees for successful careers as biomedical research scientists?

Are
the objectives, design and direction of the proposed research training
program likely to ensure effective training?

Do
the courses, where relevant, and research experiences provide
opportunities for trainees to acquire state-of-the-art scientific
knowledge, methods, and tools that are relevant to the goals of the
training program?

Does
the program provide appropriate inter- or multidisciplinary research
training opportunities?

Is
the proposed training program likely to ensure trainees will be well
prepared for research-intensive and research-related careers?

Is
the level of institutional commitment to the training program, including
administrative and research training support, sufficient to ensure the
success of the program?

Is it clear
how the proposed training program is distinguished from other externally funded
training programs at the institution?

Training Program
Director(s)/Principal Investigator(s) (PD(s)/PI(s))

Does
the Training PD/PI have the scientific background,
expertise, and administrative and training experience to provide strong
leadership, direction, management, and administration of the proposed
research training program?

Does
the PD/PI plan to commit sufficient effort to ensure the program’s
success?

For
applications designating multiple PDs/PIs: Is a strong
justification provided that the multiple PD/PI leadership approach will
benefit the training program and the trainees? Is a strong and compelling
leadership approach evident, including the designated roles and
responsibilities, governance, and organizational structure consistent with
and justified by the aims of the training program and the complementary
expertise of the PDs/PIs?

Preceptors/Mentors

Are
sufficient numbers of experienced preceptors/mentors with appropriate
expertise and funding available to support the number and level of trainees
(including short-term trainees, if applicable) proposed in the
application?

Do
the preceptors/mentors have strong records as researchers, including
recent publications and successful competition for research support in
areas directly related to the proposed research training program?

Do the
preceptors/mentors have strong records of training individuals at the level of
trainees (including short-term trainees, if applicable) proposed in the
program? Are appropriate plans in place to ensure that preceptors lacking
sufficient research training experience are likely to provide strong and
successful mentoring?

If the program will support clinical trial research experience
for the Trainees, do the mentor(s) who will supervise the Trainee(s) have the
expertise, experience, resources, and ability to provide appropriate guidance
and help the Trainee(s) to meet the timelines?

Trainees

Is
a recruitment plan proposed with strategies likely to attract
well-qualified trainees for the training program?

Is
there a competitive applicant pool of sufficient size and quality, at each
of the proposed levels (predoctoral, postdoctoral and/or short-term), to
ensure a successful training program?

Are there
well-defined and justified selection and re-appointment criteria as well as
retention strategies?

Training
Record

How
successful are the trainees (or, for new applications, other past
students/postdoctorates in similar training) in completing the program?

Has
the training program ensured that trainees are productive (or, for new
applications, other past students/postdoctorates in similar training) in
terms of research accomplishments, publication of research conducted
during the training period, and subsequent training appointments and
fellowship or career development awards?

How
successful are the trainees (or, for new applications, other past
students/postdoctorates in similar training) in achieving productive
scientific careers as evidenced by successful competition for research
science positions in industry, academia, government or other research
venues; grants; receipt of honors, awards, or patents; high-impact
publications; promotion to scientific leadership positions; and/or other
such measures of success?

To
what extent do trainees’ subsequent positions in industrial, academic,
government, non-profit, or other sectors benefit from their NRSA-supported
research training and directly benefit the broader biomedical research
enterprise?

Does the program propose a rigorous evaluation plan to
assess the quality and effectiveness of the training? Are effective
mechanisms in place for obtaining feedback from current and former
trainees?

For
applications that request short-term research training positions: Is there a record of retaining health professional trainees in research training
or other research activities for at least two years?

Additional Review Criteria

As applicable for the project proposed, reviewers will
evaluate the following additional items while determining scientific and
technical merit, and in providing an overall impact score, but will not give
separate scores for these items.

Protections for
Human Subjects

Generally not applicable. Reviewers should bring any
concerns to the attention of the Scientific Review Officer.

Inclusion of
Women, Minorities, and Children

Generally not applicable. Reviewers should bring any
concerns to the attention of the Scientific Review Officer.

Vertebrate Animals

Generally not applicable. Reviewers should bring any
concerns to the attention of the Scientific Review Officer.

Biohazards

Generally not applicable. Reviewers should bring any
concerns to the attention of the Scientific Review Officer.

Resubmissions

For Resubmissions, the committee will evaluate the
application as now presented, taking into consideration the responses to
comments from the previous scientific review group and changes made to the
project.

Renewals

For
Renewals, the committee will consider the progress made in the last funding
period, including on the Recruitment Plan to Enhance Diversity, and Training
in the Responsible Conduct of Research. Does the application describe the program’s accomplishments over the
past funding period(s)? Is the program achieving its training objectives? Has
the program evaluated the quality and effectiveness of the training experience
(and when applicable, short-term training experience), and is there evidence
that the evaluation outcomes and feedback from trainees have been acted upon?
Are changes proposed that are likely to improve or strengthen the research
training experience during the next project period (may not be applicable to
short-term training)? Does the program continue to evolve and reflect changes
in the research area in which the training occurs?

Revisions

For Revisions, the
committee will consider the appropriateness of the proposed expansion of the
scope of the project. If the Revision application relates to a specific line of
investigation presented in the original application that was not recommended
for approval by the committee, then the committee will consider whether the
responses to comments from the previous scientific review group are adequate
and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact score.

Recruitment
Plan to Enhance Diversity

Peer
reviewers will separately evaluate the recruitment plan to enhance diversity
after the overall score has been determined. Reviewers will examine the
strategies to be used in the recruitment of individuals from underrepresented
groups. The plan will be rated as ACCEPTABLE or UNACCEPTABLE, and
the consensus of the review committee will be included in an administrative
note in the summary statement.

Training in the
Responsible Conduct of Research

All applications for support under this FOA must
include a plan to fulfill NIH requirements for instruction in the Responsible
Conduct of Research (RCR). Taking into account the specific
characteristics of the training program, the level of trainee experience, and
the particular circumstances of the trainees, the reviewers will evaluate the
adequacy of the proposed RCR training in relation to the following five
required components: 1) Format - Does the plan satisfactorily
address the format of instruction, e.g. lectures, coursework and/or real-time
discussion groups, including face-to-face interaction? (A plan
involving only on-line instruction is not acceptable.); 2) Subject
Matter – Does the plan include a sufficiently broad selection of
subject matter, such as conflict of interest, authorship, data management,
human subjects and animal use, laboratory safety, research misconduct, research
ethics? 3) Faculty Participation - Does the plan adequately
describe how faculty will participate in the instruction? For renewal
applications, are all training faculty who served as course directors,
speakers, lecturers, and/or discussion leaders during the past project period
named in the application? 4) Duration of Instruction - Does the
plan meet the minimum requirements for RCR, i.e., at least eight contact hours
of instruction? 5) Frequency of Instruction – Does the plan meet
the minimum requirements for RCR, i.e., at least once during each career stage
(undergraduate, post-baccalaureate, predoctoral, postdoctoral, and faculty
levels) and at a frequency of no less than once every four years?

For renewal
applications, does the progress report document acceptable RCR instruction in
the five components described above? Does the plan describe how participation
in RCR instruction is being monitored? Are appropriate changes in the plan for RCR instruction
proposed in response to feedback and in response to evolving issues related to
responsible conduct of research?

Plans and past
record will be rated as ACCEPTABLE or UNACCEPTABLE, and the
summary statement will provide the consensus of the review committee.

Select Agent
Research

Reviewers will assess the information provided in
this section of the application, including (1) the Select Agent(s) to be used
in the proposed research, (2) the registration status of all entities where
Select Agent(s) will be used, (3) the procedures that will be used to monitor
possession use and transfer of Select Agent(s), and (4) plans for appropriate
biosafety, biocontainment, and security of the Select Agent(s).

Budget and Period of Support

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

2. Review and Selection
Process

Applications will be evaluated for scientific and technical
merit by (an) appropriate Scientific Review Group(s), convened by the
sponsoring Institute or Center in accordance with NIH peer
review policy and procedures, using the stated review
criteria. Assignment to a Scientific Review Group will be shown in the eRA
Commons.

As part of the scientific peer review, all applications:

May undergo a selection process in which only those applications
deemed to have the highest scientific and technical merit (generally the top
half of applications under review) will be discussed and assigned an overall impact
score.

Applications will be assigned on the basis of established
PHS referral guidelines to the appropriate NIH Institute or Center. Applications
will compete for available funds with all other recommended applications. Following
initial peer review, recommended applications will receive a second level of
review by the appropriate national Advisory Council or Board. The following
will be considered in making funding decisions:

Scientific and technical merit of the proposed project as
determined by scientific peer review.

Availability of funds.

Relevance of the proposed project to program priorities.

3. Anticipated Announcement
and Award Dates

After the peer review of the application is completed, the
PD/PI will be able to access his or her Summary Statement (written critique)
via the eRA
Commons. Refer to Part 1 for dates for peer review, advisory council
review, and earliest start date

If the application is under consideration for funding, NIH
will request "just-in-time" information from the applicant as
described in the NIH
Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and
conditions found on the Award
Conditions and Information for NIH Grants website. This includes any
recent legislation and policy applicable to awards that is highlighted on this
website.

Recipients of federal financial
assistance (FFA) from HHS must administer their programs in compliance with
federal civil rights law. This means that recipients of HHS funds must ensure
equal access to their programs without regard to a person’s race, color,
national origin, disability, age and, in some circumstances, sex and religion.
This includes ensuring your programs are accessible to persons with limited
English proficiency. HHS recognizes that research projects are often limited
in scope for many reasons that are nondiscriminatory, such as the principal
investigator’s scientific interest, funding limitations, recruitment
requirements, and other considerations. Thus, criteria in research protocols
that target or exclude certain populations are warranted where
nondiscriminatory justifications establish that such criteria are appropriate
with respect to the health or safety of the subjects, the scientific study
design, or the purpose of the research.

For additional guidance regarding how the provisions apply
to NIH grant programs, please contact the Scientific/Research Contact that is
identified in Section VII under Agency Contacts of this FOA. HHS provides
general guidance to recipients of FFA on meeting their legal obligation to take
reasonable steps to provide meaningful access to their programs by persons with
limited English proficiency. Please see http://www.hhs.gov/ocr/civilrights/resources/laws/revisedlep.html.
The HHS Office for Civil Rights also provides guidance on complying with civil
rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html;
and http://www.hhs.gov/ocr/civilrights/understanding/index.html.
Recipients of FFA also have specific legal obligations for serving qualified
individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html.
Please contact the HHS Office for Civil Rights for more information about
obligations and prohibitions under federal civil rights laws at http://www.hhs.gov/ocr/office/about/rgn-hqaddresses.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS
Departmental goal to ensure access to quality, culturally competent care,
including long-term services and supports, for vulnerable populations. For
further guidance on providing culturally and linguistically appropriate
services, recipients should review the National Standards for Culturally and
Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

In accordance with the statutory provisions contained in
Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal
Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal
Awardee Performance and Integrity Information System (FAPIIS) requirements.
FAPIIS requires Federal award making officials to review and consider
information about an applicant in the designated integrity and performance system
(currently FAPIIS) prior to making an award. An applicant, at its option, may
review information in the designated integrity and performance systems
accessible through FAPIIS and comment on any information about itself that a
Federal agency previously entered and is currently in FAPIIS. The Federal
awarding agency will consider any comments by the applicant, in addition to
other information in FAPIIS, in making a judgement about the applicant’s
integrity, business ethics, and record of performance under Federal awards when
completing the review of risk posed by applicants as described in 45 CFR Part
75.205 “Federal awarding agency review of risk posed by applicants.” This
provision will apply to all NIH grants and cooperative agreements except fellowships.

As specified in the NIH Revitalization Act of 1993,
Kirschstein-NRSA recipients incur a service payback obligation for the first 12
months of postdoctoral support. Policies regarding the Ruth L. Kirschstein-NRSA
payback obligation are explained in the NIH Grants
Policy Statement; more details are in the Frequently
Asked Questions. Officials at the grantee institution have the
responsibility of explaining the terms of the payback requirements to all
prospective trainees before appointment to the training grant. Additionally,
all trainees recruited into the training program should be provided with
information related to the career options that might be available when they
complete the program. The suitability of such career options as methods to
satisfy the NRSA service payback obligation should be discussed.

Inventions and Copyrights

Awards made primarily for educational purposes are exempted
from the PHS invention requirements and thus invention reporting is not
required, as described in the NIH
Grants Policy Statement.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required
to submit the Research
Performance Progress Report (RPPR) annually. Continuation support will not
be provided until the required forms are submitted and accepted.

Failure by the grantee institution to submit required forms
in a timely, complete, and accurate manner may result in an expenditure
disallowance or a delay in any continuation funding for the award.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable NIH grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000. See the NIH
Grants Policy Statement for additional information on this reporting
requirement.

Other Reporting Requirements

The institution must submit a completed Statement of
Appointment (PHS Form
2271) for each trainee appointed or reappointed to the training grant for 8
weeks or more. Grantees must submit the PHS 2271 data electronically using the
xTrain system. More information on xTrain is available at xTrain (eRA
Commons). An appointment or reappointment may begin any time during the
budget period, but not before the budget period start date of the grant year.

Additionally, a completed Payback Agreement Form (PHS Form
6031) must be submitted for each postdoctoral trainee in his or her first
12 months of support.

A notarized statement verifying possession of permanent residency
documentation must be submitted with the Statement of Appointment (PHS Form
2271). Individuals with a Conditional Permanent Resident status must first
meet full (non-conditional) Permanent Residency requirements before receiving
support.

Termination Notice: Within 30 days of the end of the total
support period, the institution must submit a Termination Notice (PHS Form
416-7) via xTrain for each trainee appointed for eight weeks or more. Trainees with service
payback requirements must notify the NIH of any change in address and submit
Annual Payback Activities Certification Forms (PHS Form
6031-1) until the payback service obligation is satisfied.

In accordance with the regulatory requirements provided at
45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have
currently active Federal grants, cooperative agreements, and procurement
contracts from all Federal awarding agencies with a cumulative total value greater
than $10,000,000 for any period of time during the period of performance of a
Federal award, must report and maintain the currency of information reported in
the System for Award Management (SAM) about civil, criminal, and
administrative proceedings in connection with the award or performance of a
Federal award that reached final disposition within the most recent five-year
period. The recipient must also make semiannual disclosures regarding
such proceedings. Proceedings information will be made publicly available
in the designated integrity and performance system (currently FAPIIS). This is
a statutory requirement under section 872 of Public Law 110-417, as amended (41
U.S.C. 2313). As required by section 3010 of Public Law 111-212, all
information posted in the designated integrity and performance system on or
after April 15, 2011, except past performance reviews required for Federal
procurement contracts, will be publicly available. Full reporting requirements
and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and
Conditions for Recipient Integrity and Performance Matters.

4. Evaluation

In carrying out its stewardship of human resource-related
programs, the NIH may request information essential to an assessment of the
effectiveness of this program from databases and from participants themselves. Participants
may be contacted after the completion of this award for periodic updates on
various aspects of their employment history, publications, support from
research grants or contracts, honors and awards, professional activities, and
other information helpful in evaluating the impact of the program.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Because of the difference in individual Institute and Center
(IC) program requirements for this FOA, prospective applications MUST consult the Table
of IC-Specific Information, Requirements and Staff Contacts, to make sure
that their application is responsive to the requirements of one of the
participating NIH ICs. Prior consultation with NIH staff is strongly encouraged.